I. Field of the Invention
Many surgical procedures expose operating personnel to the patient's blood and other body fluids, as well as to water and other liquids used for irrigation purposes during some surgical procedures. Such "operating fluids" may carry contagious diseases, such as the AIDS virus.
This invention relates to a disposable surgical isolation apparatus that completely protects operating personnel from contact with contaminated operating fluids, while providing full access to the patient for the hands of the operating personnel and for optical surgical instruments such as endoscopes. This invention eliminates the need for operating personnel to wear facemasks or cumbersome full-body protective clothing. Embodiments of the invention include provisions for sampling and collecting operating fluids during the surgical procedure; and for safe disposal the entire surgical isolation apparatus, together with any collected operating fluids, following the surgical procedure. The preferred embodiment is simply constructed of two sheets of transparent plastic, heat-sealed at the edges, to provide an economical device that can be disposed of after it has been contaminated.
II. Description of the Prior Art
The most popular current approach to management of operating fluids during operations like transurethral prostatectomies is simply to channel the fluids down the exterior of a surgical drape into a collection bag, which in turn may empty into a hose leading to a floor drain. The following U.S. Pat. Nos. describe variants on that approach: 4,414,968 (Amin); 4,462,396 (Wichman); 4,489,720 (Morris, et al.); 4,890,628 (Jackson); 4,378,794 (Collins); 4,471,769 (Lockhart); 4,570,628 (Neal); 4,596,245 (Morris), and 4,974,604 (Morris). Only in combination with full-body protective garments such as those disclosed in U.S. Pat. No. 4,535,481 (Ruth-Larson, et al.) and protective face shields like those disclosed in U.S. Pat. Nos. 4,834,068 (Gottesman) and 4,848,322 (Dash, et al.) can the foregoing arrangements provide any protection from contaminated operating fluids for the operating personnel. And even combined with such measures, protection is far from complete because operating fluids may still spatter or spill, contaminating the operating room environment.
U.S. Pat. No. 4,903,710 (Jessamine, et al.) discloses a drape of that attaches to the legs and feet of a patient in the lithotomy position, screening the patient's genital area from the physician and enclosing the working area at the back (i.e., facing away from the patient) and sides only (not at the front facing toward the patient, or at the top) by means of panels attached to the patient's lower legs (as shown in Jessamine's FIG. 5). Operating fluids that do not spatter or spill outside the partial enclosure formed by the drape can be channeled into a bucket (as shown in Jessamine's FIG. 3). There is no provision for collection of all operating fluids, and Jessamine's drape provides only partial protection for operating personnel standing in certain positions during the operation--for example, anyone standing near the patient's head would be unprotected. And, since Jessamine depends upon the patient's legs to support the drape, it is only usable for surgical procedures in which the patient is in the lithotomy position.
The purpose of the invention described in U.S. Pat. No. 4,926,882 (Lawrence) is to isolate the skull or ribcage of a cadaver from a person performing an autopsy, while providing an instrument port 24 to accommodate the shaft of an oscillating bone saw. When a craniotomy is to be performed, an adhesive strip 24 seals the bag around the shoulders of the cadaver; to remove the spinal chord a pair of adhesive strips are used, one around the neck 121 and the other just below the waist 122. Stiffening ribs 34, arranged in a cruciform pattern with its center at instrument port 24, spread the drape and hold it away from the working area while the sawing operation is being performed, but once the saw is withdrawn there is no provision for continued support of the drape. Nor is there need for such provision, since as Lawrence explains there is no flowing blood or other fluid in an autopsy, and the main reason any protection is needed is because the bone saw tends to disperse quiescent fluids into the air as an aerosol, a phenomenon that stops at the conclusion of the sawing operation. Thus, Lawrence does not provide any manual access through the shield to the working area. Lawrence also makes no provision for collecting operating fluids, and would be unusable for procedures requiring much irrigation even if it could be adapted for use on live patients.
U.S. Pat. No. 4,489,720 (Morris, et al.) discloses a drape intended for use during Cesarean deliveries. According to Morris, ordinary fluid management devices (in which the blood and other fluids run down the outside or upper surface of the drape and are channeled into a bag or receptacle attached to, or formed on the outer surface of the drape) are inappropriate for Cesarean deliveries because the patient lies too flat, or on one side, apparently providing insufficient slope to drain fluids into a bag attached outside the drape. Morris attempts to solve the problem by attaching the bag 19 to the inner surface of the drape, so it hangs down between the patient's legs. Fluids enter the bag through a fenestration 21 communicating between the upper surface of the drape and the bag 19. A flap 22, fitted with an adhesive strip 23, allows the bag to be sealed after the operation to prevent spilling of fluid as the sheet is removed. (Col. 3, line 64 through col. 4, line 5).
The resulting arrangement, however, is a complex multi-piece construction. And it is specifically adapted to a particular procedure: a Cesarean delivery. Most importantly, it does not provide any protection for the physician from contaminated blood and body fluids.
U.S. Pat. No. 4,471,769 (Lockhart) discloses a drape having one hammock-shaped member 8 that can be attached to the physician's chest by means of an adhesive strip 40, forming a concave surface with a drain hole 38 at its bottom. Again, however, contaminated operating fluids flow down an open trough directly in front of the physician's face, with no protection for the physician or other operating personnel.
There is a need for a surgical isolation apparatus that can accommodate a variety of surgical procedures, and that ensures complete isolation and containment of contaminated operating fluids while providing access to the operating area for the hands of the operating personnel, and for optical instruments such as endoscopes.